Biologic Abatement and Capturing Kids' Outcomes and Flare... | NCT04891640

ID	Type	Description	Link
: GRT-00001036	Other Grant/Funding Number	PCORI

Status Module

Name	Class
Patient-Centered Outcomes Research Institute	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TNFi Standard Therapy	Active Comparator	Continue fixed standard treatment (i.e., no change from current therapy)	Other: Standard TNFi Therapy
TNFi fixed longer dosing intervals	Experimental	Fixed longer dosing intervals of TNFi (i.e., increased time between doses)	Other: TNFi fixed longer dosing intervals
TNFi Therapy Withdrawal	Experimental	Stop TNFi treatment	Other: Stop TNFi treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard TNFi Therapy	Other	Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.	TNFi Standard Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Juvenile Spondyloarthritis (JSpA) flare	JSpA flare is defined as clinically meaningful worsening in ≥3 of the following: caregiver/patient assessment of well-being, physician assessment of disease activity, caregiver/patient assessment of pain, physical function, and active joint count. Meaningful change for well-being, disease activity, and pain are an increase of ≥2 on visual analogue scale (range 0-10 with higher scores indicating poorer well-being, higher disease activity, and higher magnitude of pain). Meaningful change in function is defined as ≥3 unit change in the PROMIS mobility or upper extremity T-scores. The Patient-Reported Outcomes Measurement Information System (PROMIS) short forms include 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation of 10. Active joint count is defined as the number of joints with swelling or, in the absence of swelling, limitation of motion accompanied by pain or warmth as per the physician examination.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Pain interference (as measured by the PROMIS short form)	Pain interference (as measured by the PROMIS short form) of children with spondyloarthritis in the three treatment arms. The PROMIS short form is a validated questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life.The PROMIS short form includes 8 questions and a T-score of '50' represents the healthy population mean score with standard deviation equal to 10.

Eligibility Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Phoenix Children's

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36755328	Derived	Weiss PF, Sears CE, Brandon TG, Forrest CB, Neu E, Kohlheim M, Leal J, Xiao R, Lovell D. Biologic Abatement and Capturing Kids' Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA): study protocol for a randomized pragmatic trial. Trials. 2023 Feb 8;24(1):100. doi: 10.1186/s13063-022-07038-6.